Female Infertility Due to Diminished Ovarian Reserve Clinical Trial
Official title:
An Open-Label Randomized Controlled Trial (RCT) of 6 Weeks of Human Growth Hormone (HGH) Prior to Ovulation Induction for In Vitro Fertilization (IVF)
Verified date | February 2020 |
Source | Center for Human Reproduction |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Synthetic human growth hormone (HGH) has been available for more than a decade for specific
indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under
off-label use) for improving ovarian function have shown that a combination of traditional
gonadotropin ovulation induction protocols, with addition of HGH is effective in increasing
pregnancy rates, but not increasing egg production after IVF in women with documented
diminished ovarian reserve (DOR). The investigators hypothesize that by initiating HGH at
least 6 weeks prior to IVF start, the investigators will be able to increase production of
oocytes and further improve pregnancy chances. This hypothesis is based on prior observations
of effects of growth hormone on small antral follicles and the fact that prior studies
utilized HGH principally only during ovulation induction itself.
The investigators plan to recruit 30 women (15 in each group) to an open label randomized
controlled trial of HGH for augmentation of ovarian response among women with documented DOR
and poor prior response to ovulation induction.
Eligible participants will be women < 45 years with documented history of prior retrieval of
2 or fewer oocytes while on maximal ovulation induction despite prior supplementation with
dehydroepiandrosterone (DHEA).
Women will be treated with 1.9 mg (5.7 units) of HGH per day, beginning about 6 weeks before
start of their treatment cycle. Cost of treatment with HGH will be a cost to the
participating patient. HGH will cost the patient approximately $800 per week of treatment.
Patients who are randomized to the non-HGH treated group, and do not conceive, will in the
following cycle be offered HGH supplementation outside of this clinical trial. This
subsequent cycle will not be part of the study dataset and patients will also be responsible
for the cost of HGH.
Even with only 7 patients in each group, this trial will have a 99% power (error 0.05%) to
detect a mean increase to 4 oocytes in the treated group. The investigators plan to recruit
15 patients in each group to allow for possible dropouts.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | June 2022 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
Inclusion Criteria: - The study will be limited to women with Poor Response to prior treatment with evidence of diminished ovarian reserve with 2 or fewer oocytes in a previous ovulation induction cycles with maximal gonadotrophin stimulation. All women in this study will be <45 years old. Exclusion Criteria: - Cardiac disease, evidence of glucose intolerance |
Country | Name | City | State |
---|---|---|---|
United States | Center for Human Reproduction | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Center for Human Reproduction |
United States,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oocytes retrieved for IVF | 8 weeks after starting intervention | ||
Secondary | Clinical Pregnancy Rates | Presence of an established clinical pregnancy as evidenced by gestational sac with active fetal heart beat | 12 weeks after starting intervention |
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